Recall Z-2881-2020 ยท IYE Accelerator, Linear, Medical
Klarity Medical Products LLC
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
| Date | Jul 31, 2020 |
| Status | Terminated |
| Reason | Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times. |
| Root cause | Component design/selection |
| Action | On July 31, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers, informing them that vacuum bags may experience product failure wherein the bags fail to maintain an adequate vacuum over a required period of time. The loss of vacuum can lead to treatment inaccuracy due to shift of patient location. Customers were instructed to: 1. Inspect current inventory to locate any affected product. 2. Remove product from service. 3. Destroy and dispose of product (the firm recommended cutting up and disposing with normal trash). Klarity will replace affected bags or rei |
| Quantity | 111 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132124 | KLARITY VACUUM BAG, KLARITY MOLD CUSHION Klarity Medical Products, LLC, Nov 1, 2013 |